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AIDS Treatment News
AIDS Treatment News
June 20, 1997
Contents:
For subscription, donation and editorial information and to read our Statement of Purpose, visit AIDS Treatment News' page here at The Body.
FDA Explores New Antiretroviral
Trial Designs: Interview with David Feigal, M.D.
by John S. James
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On July 14 and 15, at a public meeting of the FDA Antiviral
Drugs Advisory Committee, experts from government, industry,
academia, and the community will explore new approaches to
designing antiretroviral drug trials, based on current
knowledge of HIV disease (see announcement in AIDS TREATMENT
NEWS #272, June 6, 1997). On June 12 we interviewed David
Feigal, M.D., M.P.H., Director of the Division of Antiviral
Drug Products of the U.S. Food and Drug Administration, about
current problems in clinical trials, what is needed now, and
the FDA's plans for the July meeting.
Background
A new anti-HIV drug can get "accelerated approval" by showing
statistical proof of benefit in viral load and other
indicators of HIV disease progression. But then the drug must
undergo much larger "confirmatory trials," to show
statistical proof that it reduces death or major
opportunistic infections. These large trials are sometimes
called "clinical endpoint" studies, because a participant is
recorded as having reached an endpoint in the trial when a
major disease event occurs. Because clinical endpoints are
relatively rare, and depend on many factors besides the drugs
used, these trials usually need to be very large -- usually
with more than a thousand volunteers -- to get statistical
proof that one of the drug regimens being tested is better
than another. These large confirmatory trials have become
increasingly problematic as knowledge of HIV disease has
advanced, and volunteers do not want to continue using
treatments which are not working for them.
The ideas which the FDA is now exploring, which it explained
to treatment activists in a community meeting on May 16,
would leave accelerated approval as it is today. But
companies could choose whether to run the current kind of
clinical-endpoint trial, or a new kind of confirmatory trial,
which in many cases could record effective viral suppression
over a period of time instead of recording clinical
endpoints. In these trials, each volunteer would quickly stop
any treatment which was not suppressing the virus, be counted
then as having reached a treatment failure, and switch to
whatever treatment they and their physician decided. This
would be very different from the current system, where
participants are encouraged to stay on their assigned study
regimen until the trial is over, or until they become
seriously ill -- which allows viral resistance to develop
when participants stay on regimens which do not suppress the
virus completely.
By using modern understanding of HIV to individualize the
process of dropping ineffective regimens, the new approach
should result in more ethical trials, which will be easier to
recruit because they are more attractive. Also, these trials
should avoid the bias which now occurs when volunteers
recognize treatment failure which is not handled in the
protocol, and drop out on their own.
Interview with Dr. Feigal
AIDS Treatment News: The FDA is considering changes in the
requirements for confirmatory trials of antiretrovirals, to
not require clinical endpoints in some cases. What is the
main problem these changes are intended to solve?
Dr. David Feigal: I believe that the central problem with
current clinical trials is not clinical endpoints, but the
concern about having suboptimal study arms. For example, a
study may compare two treatment regimens: an old one that we
know something about, and a new one, to see if the new one is
better. People do not want to put the volunteers at risk for
losing drugs that could personally benefit them, by
administering the drugs in such a way that the study
participants are likely to become resistant, or to become
intolerant in some other way.
And because many of the drugs are related to each other,
there really are not that many of them. Even though eleven
antiretrovirals have been approved and there are several
others with more limited availability, many have overlapping
resistance, or similar toxicities for patients, that limit
what you can do with them.
So we have looked at what are the ways that a treatment
regimen can be suboptimal. And much has been learned over the
last several years, from studies of drugs' effects on viral
load. We have become quite convinced that viral load measures
are sensitive enough to detect when a drug regimen is
effective, and they are also sensitive enough to detect when
a regimen has lost its effectiveness, which can happen from a
variety of reasons.
Back when there were not many drugs, there were not many
choices, other than take one for as long as you could; there
was only one drug, or only two that were available. But now
that we are individualizing therapy, there is much more in
the art of assessing whether a given combination of drugs is
producing an adequate response, and trying to get an adequate
duration of response. So whether or not the person is someone
who is at risk for developing infections or clinical
endpoints, we need to make sure that people take the drugs in
such a way that they will respond to them as well as
possible, for as long as possible, and with the least
interference with the use of whatever other drugs are left
for that person to take.
ATN: Then the basic idea seems to be to design the protocol
so that people stay on the therapy as long as it is working
for them, in terms of keeping viral load completely
suppressed?
DF: That's right. If you had a drug combination that had a
good response in a group, the old approach would be that you
take those drugs until you had a clinical event, or until the
study ended, or until CD4 counts fell in half, or something
else like that. The new approach would say that once someone
starts on a study regimen, the first thing we will do is test
whether or not that person got an adequate [viral load]
response. If not, that is a failure already, and there is no
reason for that person to continue to take that particular
regimen. And for the participants who get a good response,
then of course we want to see how long that response will
last.
This is a different approach than we had in the past. It is
not the fault of some of the old trials, which did not even
have real-time virology [viral load tests which get accurate
results without having to be batched and run later] available
to them at the time those studies were done. But in the past,
many of those participants would not have had a satisfactory
response in the first place, and some of them would have lost
the response; then they just were followed, while their
viruses were developing resistance to the drugs that they
were replicating in the face of. So we think we can do the
trials in a way that is not only more ethical, but also will
provide the kind of information useful in clinical practice.
ATN: You will be looking at something like a 48-week period
for the main part of the study?
DF: Yes, one of the major goals of HIV therapy is to be able
to have an effect that lasts as long as possible. You cannot
determine if something works for a long time with a four-
month study. We want the study duration to be long enough to
show us how long some of these drugs work. Of course we would
like them to work longer than a year; if we had a well-
tolerated regimen, it would be great if it worked for
multiple years. But a year seems to be a reasonable
compromise.
If a company has a new agent that is particularly promising,
or has some information based on earlier data, it could seek
accelerated approval, and then get the additional data over a
longer time period.
During that time, the trial would follow people who had
satisfactory responses, and then try to understand why some
patients were losing their response. Were they losing it
because resistance had developed? Because they had started a
new medication for some other reason, and there was drug
interaction? Were they losing it because the regimen was too
hard to comply with, and they became careless about how
faithfully they took the medication? Much of this information
we never systematically collected; we had bits and pieces of
it. But this is what you need to know to use these drugs in
the modern era.
ATN: I understand that in the first part of these trials, you
will look for the total viral load drop?
DF: Part of the reason for doing that is that there still is
a need to understand how potent the different drugs are. And
for that, you need to have complete data on people, at least
for a short period of time.
So we hope that one feature of the study design will be an
early study period, to assess how many patients get an
adequate drop -- and that companies will study a wide enough
range of viral load to get a good measurement of that.
One question is, what is the best way to characterize the
degree of viral load drop due to a treatment? Should it be
the percent of patients who become undetectable by current
assays? Or should it be the size of the initial drop in
virus? It is not either/or; you want to know both. If we just
wanted to know the percent of patients whose viral load
became undetectable, that would create an incentive to just
study early patients with low viral levels; those are the
easiest patients to suppress.
We think we will get a better picture, and a better estimate
of the potency, if we say that we want to answer our four big
questions:
- How deep is the viral load drop;
- What percentage of patients get a satisfactory response, on
an absolute scale [not in comparison with the size of the
response in other treatment arms];
- How long does the response last; and
- Why is the response lost, and what are the consequences of
losing it?
These are the kinds of questions that we want to answer with
the protocols.
ATN: Concerning the July 14-15 meeting of the Antiviral Drugs
Advisory Committee, what is the format and purpose of the
meeting?
DF: We have asked the companies, academic centers, and
government study groups that have data -- data that can
answer some of these questions that are needed to design
these protocols -- to come in, not to present their whole
studies, but to present parts of them. For example, some
design questions would be influenced by how much variability
there is in the same person when you just measure the virus
from day to day. So we invited people who have done studies
which generated data on variability, asked them to come in
and make a presentation.
The format of the meeting will be for us to break the
questions apart. If the question is, for example,
determination of treatment loss of response (so-called
"treatment failure," which I prefer to call loss of
response), how much do people bounce when they are at a low
viral load level? How often do you see someone who is at a
very low level (of virus) have a little spike, but nothing
else happens over time? Many of these trials were not trying
to individualize therapy, so they have observed what happens
over time; they will be able to help us design the studies so
that one does not yank a therapy too quickly, because of
background noise, and give us a better sense of how the
assays perform.
If you step back and look at the big picture of what we are
asking the Committee, we are asking a couple of very
fundamental questions. One, is there adequate evidence that
there is clinical benefit from lowered viral load per se? If
reducing viral load really is a goal of therapy, then that
should be the indication of the therapy. Now the drug
labeling sort of says, "Indicated to treat HIV." That does
not really tell you exactly what you are doing and how you
are doing it.
We are asking, for antiviral drugs, have we moved to the era
where we should focus in on the virus itself?
The other change, which is a little more subtle, is that in
the past, when we looked at surrogate markers like the CD4
count, or viral load drop, the emphasis was on getting
complete data on everyone for a fixed time period, with
everyone trying to stay on drug. We wanted to see which
treatment had the better group average response. Obviously
one of the problems with those studies was that the patients
whose markers were doing poorly left the study, and
artificially affected the measure -- making the counts look
better than they were, because people with unfavorable counts
would drop out.
Now, instead of asking what is the average effect of taking
the regimen for a period of time, we are asking what
percentage of people get an adequate response, and how long
does that last? It is much more of a time-to-event. You only
stay on a therapy if it works; and you only keep taking it if
it continues to work. We are essentially asking the
Committee, is the data on viral load good enough that we can
rely on it to do this?
Although the issue is phrased as whether we are leaving
clinical endpoints, from our standpoint we are not. We hope
that companies will continue to study new products in a
spectrum of HIV conditions -- including patients with very
low CD4 counts and high viral load, that are at high risk for
developing infections and other complications. In those
trials, they should be able to tell whether or not totally
suppressing the virus with one regimen is just as good as
totally suppressing it with another. Or is there some other
problem that emerges?
Similarly, there should be studies of patients with early
disease, to try to get at the questions you want to answer
about early disease.
To us, the issue is not are we going to stop studying
patients that are developing infections. The real issue is to
see how well we can combine drugs, to individualize therapy,
and to see how useful a product is within a combination, in
different stages of the disease.
ATN: In this meeting, will there be any focus on the problems
of getting the companies to work together, and be willing to
have their drugs tested with competitors' drugs?
DF: I am sure that this issue will be raised in the public
comment section. I know that has been an important issue for
the community, and for practitioners who want to know
information about certain options. It is clear that there are
times when decisions about what types of studies to do are
made by companies based on their interests in seeing what
they can do with their own products; as you know, several of
the companies have multiple products. They may well be
missing opportunities to find combinations which are
particularly effective, which would require testing their
drug along with their competitor's product. I hope that some
of the independent studies that are often done by groups such
as the ACTG will level that playing field a little bit.
Given the way that the drug development structure is based
often on economic incentives, a company would have to see
that if they found that their product was useful with their
competitor's product, that would have some economic advantage
to them. Their first take may well be that this would not be
as advantageous as selling two of their own products, so they
will test that first.
But there is much screening that needs to be done, and many
products to be tested. Hopefully, by basing clinical trials
more on viral load and less on studies that look for disease
progression, the studies will be small enough that we will be
able to more efficiently screen promising combinations. And
studies that in the past might only have been feasible with
large-scale corporate or government sponsorship could then be
done on a more modest scale, to identify hot leads to follow.
ATN: Is there a way for the public to submit written comments
to be considered by the Committee, if one is not going to be
there in person?
DF: Send them to Rhonda Stover, the executive secretary. They
can be provided as background to the Committee members,
either in the mailing we send them before they arrive, or in
their packet at the time of the meeting.
[Mail or fax comments to: Rhonda Stover or John Schupp,
Center for Drug Evaluation and Research (HFD-21), Food and
Drug Administration, 5600 Fishers Lane, Rockville, Maryland
20857, phone 301/443-5455, fax 301/443-0699. Those who would
like to speak during the public comment period at the
meeting, July 14 from 11 a.m. to noon, should notify them by
July 7. The meeting will be 8:30 a.m. to 5:00 p.m. each day,
in Room 204 of the Armory Place, 925 Wayne Avenue, Silver
Spring, Maryland, walking distance from the Silver Spring
Metro stop.]
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Protease Inhibitors: FDA Warns Doctors
of Diabetes Risk
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On June 11 the U.S. Food and Drug Administration warned AIDS
physicians that there might be a small risk of developing
diabetes due to use of protease inhibitors. Eighty three
cases had been found, of which 27 required hospitalization
and six were life-threatening, out of an estimated 110,000
U.S. patients now prescribed these drugs. Even allowing for
major under reporting, the "attack rate" appears to be well
under one percent -- and it is not known for sure that the
drugs caused the illness. There is no evidence that any of
the four available protease inhibitors is better or worse
than any other.
The FDA did NOT recommend stopping protease inhibitors as a
result of this information, but wanted health professionals
to be aware of the possible problem, so that patients will be
tested early for diabetes if symptoms develop.
"HIV patients on protease inhibitor therapy should know the
warning signs of hyperglycemia and diabetes: increased thirst
and hunger, unexplained weight loss, increased urination,
fatigue and dry, itchy skin." (quoted from FDA Talk Paper,
"Health Advisory for Newest Class of AIDS Drugs," June 11,
1997).
Letter to Doctors
The following letter was sent to about 13,000 physicians and
other health-care professionals, who account for about 95% of
all HIV prescribing in the U.S.
Subject: Reports of diabetes and hyperglycemia in patients
receiving protease inhibitors for the treatment of human
immunodeficiency virus (HIV)
Dear Health Care Professional:
The Food and Drug Administration would like to call to your
attention recent post marketing reports of new onset diabetes
mellitus, hyperglycemia or exacerbation of existing diabetes
mellitus occurring in HIV-infected patients receiving
protease inhibitor therapy. At the present time there exists
no conclusive evidence establishing a definite causal
relationship between protease inhibitor therapy and the
incidence of diabetes and hyperglycemia. Based on present
reporting, we believe the occurrence of this event is
relatively infrequent. As such, patients for whom these
products are indicated should not discontinue therapy without
consulting their health care professional. However, given the
potential seriousness of this complication, we believe that
patients and health care professionals should be notified of
this information.
Summary of Reports
* As of May 12, 1997, there have been 83 cases reported to
FDA of diabetes mellitus or hyperglycemia in HIV-infected
patients who were receiving anti-retroviral protease
inhibitor therapy; 27 of the 83 cases were reported to
require hospitalization. Fourteen patients were known to be
diabetic at baseline; for these patients, there was a loss of
glucose control. The average time of onset was approximately
76 days after initiating protease inhibitor therapy, but
occurred as early as four days after starting therapy. Five
cases of diabetic ketoacidosis occurred, including patients
who were not reported to be diabetic at baseline; however,
the baseline status of these patients is not well
characterized.
* Some patients required either initiation or dose
adjustment of insulin or oral hypoglycemic agents for the
treatment of these events. On an average, fifty percent of
patients discontinued their protease inhibitor therapy as a
result of this acute adverse event. Hyperglycemia persisted
in some patients after protease inhibitor therapy was
withdrawn including patients not known to be diabetic at
baseline; however a causal relationship between protease
inhibitor therapy and these events has not been established.
* Many of these reports occurred in patients with
confounding medical conditions, some of which required
therapy with agents that have been associated with the
development of diabetes mellitus or hyperglycemia.
* Diabetes and hyperglycemia have been reported to varying
degrees for Crixivan® (indinavir), Invirase®
(saquinavir), Norvir® (ritonavir) and Viracept®
(nelfinavir).
"FDA will continue close monitoring for additional events. We
encourage all health care professionals to report any cases
of diabetes or hyperglycemia, or any other serious toxicity
associated with the use of protease inhibitors, to the FDA's
MEDWATCH program at 1-800-FDA-1088/fax 1-800-FDA-0178; or to
the respective pharmaceutical manufacturers: [phone numbers
included in the letter]."
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1592: Protests on Small Access Program
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1592 (generic name abacavir), an important experimental HIV
treatment being developed by Glaxo Wellcome, has been in
development for about nine years but has so far only been
given to 200-300 people (it was first tested in people in
1995). Glaxo has announced a small "compassionate use"
program, scheduled to start in July, to make 1592 available
to 2500 adults and children worldwide (in countries where the
drug is already in clinical trials). In this program, 1592
will be distributed at only about 50 sites in the U.S.;
according to Glaxo, these sites will accept patients referred
to them. The company also plans to start a larger "expanded
access" program, hopefully by early 1998, although no date
has been set. [For more information on 1592, see AIDS
TREATMENT NEWS #271 (May 16, 1997),
#261 (December 20, 1996),
#259 (November 15, 1996), and #253 (August 23, 1996).]
AIDS advocates are concerned that thousands of people with no
other treatment option may be unable to obtain this new drug
for at least the next six months, due to the small size of
the initial program.
Glaxo has given two reasons for the limitations of the
compassionate use program: production difficulties in scaling
up the manufacturing process, and limited human experience
with the drug. The company points out that it plans to
increase human use of 1592 from about 250 now, to about 4500
in six months: 2000 in phase III trials, plus 2500 in open-
label compassionate use. Most advocates expect that 2500
slots will be far too few for persons who have no other
options; they acknowledge that there are production
difficulties but suspect that capacity is largely determined
by decisions on how much money and other resources are made
available, especially with a drug like 1592 which does not
appear to be particularly difficult to manufacture. Also,
they believe that persons with no other satisfactory options
should be allowed to take the risk of using a drug early in
human testing, pointing out that ddI was made available
before approval to almost ten times as many people as planned
for 1592, based on about the same human experience as 1592
has now.
Programs for pre-approval expanded access to AIDS treatments
have become far more restrictive in the last year and a half.
The PWA Health Group researched this history, and noted the
contrast between the large expanded access programs for ddI,
ddC, d4T, and 3TC (the largest expanded access program of
all, by Glaxo Wellcome), compared to far smaller programs for
the protease inhibitors saquinavir, ritonavir, and indinavir
-- and for the initial "compassionate use" program for 1592
(with a larger "expanded access" program announced for later,
but with no specifics given).
Some of the protests are:
* The 1592 Access Coalition, a group of over 20 activists,
are circulating a sign-on letter to AIDS organizations (see
below). The letter will be sent to the CEO of Glaxo Wellcome.
The 1592 Access Coalition is also working with the White
House, through the Office of National AIDS Policy director
Sandra Thurman.
* Activists are planning a national boycott of Glaxo's over-
the-counter product Zantac. For more information, contact ACT
UP/Golden Gate, 415/252-9200, fax 415/252-9277, email actup@actupgg.org.
* On May 31, 300 AIDS activists from New York, Philadelphia,
and Cleveland conducted a die-in at the POZ Life Expo in New
York, protesting lack of access to experimental AIDS
medications by persons who need them. After learning of the
planned demonstration, Glaxo Wellcome withdrew from the Expo.
At this time no information has been released on exactly when
the July access program will start, nor what number
physicians or patients should call to register. More
information may be available within a week or two.
1592 Access Coalition Consensus Letter
The following letter, addressed to Robert Ingram, Chief
Executive Officer of Glaxo Wellcome, is being circulated to
AIDS organizations for sign-on. Organizations can sign the
letter by faxing their endorsement to Linda Grinberg at FAIR,
310/471-4565. If you have any questions or need more
information about 1592 or the proposed access program,
contact Ron Baker at 415/487-8065. If you want to join the
Coalition or be more involved in the protests, leave a
message for Jeff Getty at ACT UP/Golden Gate, 415/252-9200.
Re: Development of Abacavir (1592)
Community treatment advocacy groups and activists watch with
growing concern as the major pharmaceutical companies
continue to reduce the size of compassionate use and expanded
access programs for promising new AIDS drugs. The limited
1592 compassionate use program proposed by Glaxo Wellcome
provides the most recent example of the industry's misguided
policy on early access.
The individuals and organizations listed below call on Glaxo
Wellcome to take the following actions regarding 1592:
I. Compassionate Use Program.
A. Commit to significantly increase the size of the
compassionate use program scheduled to begin in July 1997.
(It is anticipated that more than 10,000 patients worldwide
may need 1592);
B. Triage patients to ensure those in most critical need are
given highest priority;
C. Provide monthly progress reports to designated community
representative(s) regarding production capacity and patient
enrollment;
D. Describe procedures to ensure equity of access and
avoidance of preferential treatment to patients at selected
sites;
E. Provide the drug to patients who cannot access the
medical sites designated by Glaxo. (Traditionally,
compassionate use programs reach patients through their
healthcare providers.)
II. Expanded Access Program
A. Initiate an expanded access program at the earliest
possible date in 1997;
B. Provide details regarding inclusion/exclusion criteria,
size and scope of program, distribution plans, and other
pertinent information as soon as possible.
III. Protocols and Clinical Trial Sites
Provide information on 1592 protocols and identify clinical study
sites, as promised, immediately.
IV. Accelerated Approval
A. File for accelerated approval of 1592 no later than March
1998;
B. Initiate rolling data submissions to FDA as soon as
possible.
Promising new therapies such as 1592 must become available
as soon as possible to people without treatment options who
face disease progression or death. Community advocates and
activists call upon Glaxo Wellcome and all AIDS drug
manufacturers to recognize that people with advanced disease
have a basic right to speedy access to new experimental
therapies when all other treatment options have failed.
"We look forward to receiving your response to our concerns
regarding 1592."
Sincerely,
1592 Access Coalition
Ron Baker, Bill Bahlman, Peter Cashman, Sally Cooper, Paul
Davis, Martin Delaney, Jeff Getty, David Gilden, Linda
Grinberg, John Iverson, Cleve Jones, Kate Krauss, James
Learned, Jules Levin, Andrew Lipschitz, M.D., Joel Martinez,
Eileen Mitzman, Leigh Paidolfino-Danas, Lili Rundback,
Matthew Sharp, and Theo Smart
The letter has only been available for a few days before this
article went to press. The following AIDS organizations have
endorsed it so far:
ACT UP/East Bay
ACT UP/Golden Gate
ACT UP/Los Angeles
ACT UP/New York
AIDS Action Now (Toronto)
AIDS Service Center, Pasadena
APLA (AIDS Project Los Angeles)
Center for AIDS: Hope and Remembrance Project
CRIA (Community Research Initiative on AIDS)
FAIR (Foundation for AIDS and Immune Research, formerly the
Linda Grinberg Foundation)
GMHC (Gay Men's Health Crisis)
Healing Alternatives Foundation
Log Cabin Republicans
Mothers' Voices
NATAP (National AIDS Treatment Advocacy Project)
Project Inform
San Francisco AIDS Foundation
TAG (Treatment Action Group)
Comment
Whatever happens with access to 1592, what is most important
is to use all antiretrovirals well. It is widely agreed that
a single drug should not be used by itself, and should not be
added by itself to a regimen which is failing to control the
virus. Otherwise the virus is likely to develop resistance to
the new medication, and the patient will lose most or all
future benefit of using that drug, or other treatments to
which the virus may be cross resistant. To help prevent this,
at least two new drugs should be added at the same time.
One reason for the importance of 1592 is that many people
have already used up most of their antiretroviral options, as
a result of the way these drugs were used in the past, when
less was known about HIV treatment. 1592 may be a potential
addition to the one or two treatments they have left.
Those who cannot get access to a combination which is
promising for them might choose to wait to change treatments,
if possible, until a better regimen is available -- rather
than adding new drugs one by one when they become accessible.
None of this justifies any delay in making a new treatment
available to patients and physicians (such as the idea of
holding back a drug until it can be provided with other
drugs). Each person is different -- and many now have one or
more approved treatments which they could use, but also need
something else, such as 1592, to put together a promising
antiretroviral regimen for themselves.
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Help Wanted, Washington D.C.: "Network Correspondent"
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"Network Correspondent"
"National, nonprofit AIDS advocacy organization seeks
individual to communicate with and grow its grassroots
network of community-based member organizations nationwide.
Applicant must have the ability to rapidly and effectively
translate and communicate legislative activities and policy,
as well as member benefits, to a national base of
constituents. Candidate should have one to two years
experience working in a nonprofit, government, or lobbying
organization with demonstrated experience writing and
communicating legislative policy issues. Experience in
writing fax alerts and educational documents a plus. Women,
people of color and HIV positive individuals are strongly
encouraged to apply. Send cover letter and resume to: AIDS
Action, 1875 Connecticut Avenue, NW, Suite 700, Washington,
D.C. 20009."
Comment
For many years the AIDS Action Council has been better at
inside lobbying than at grassroots organizing. Community
organizers have not been given the status and authority
within the organization which they would need to be
effective. It is possible that the right person could do
important work in this job, but applicants should be aware of
the history.
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San Francisco, Oakland: Treatment Access Workshop, June 27,
July 11, July 18
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A three-hour workshop, "Providing Access to Treatment: New
Drugs, Clinical Trials, and the Internet," for AIDS
professionals and volunteers will be held three times: in
Oakland June 27 (at the Center for AIDS Services), and San
Francisco July 11 and July 18 (UCSF Mission Center building).
Topics include the new Federal guidelines for HIV treatment
(not yet released as this issue goes to press), linking
clients with clinical trials, and HIV information on the
Internet.
This workshop is intended for: registered nurses (who can
receive 2.5 hours CME credit), other nurses, social workers,
case managers, counselors/peer counselors, benefits
counselors, patient advocates, treatment advocates,
patient/client educators, hotline workers and volunteers, and
other AIDS service providers.
There is no charge for this workshop, which runs from noon to
3 p.m. But space is limited, and advanced registration is
requested. To register, or for more information, contact the
Community Consortium, fax 415/476-4734, or phone 415/502-
0657.
Copyright 1997 by John S. James. Permission granted for noncommercial reproduction,
provided that our address and phone number are included if more than short quotations are used.
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This article was provided by AIDS Treatment News.
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